Pharmacogenomics of GLP1 Receptor Agonists

• Status: Terminated
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Healthy volunteers were recruited from the Old Order Amish population in Lancaster County, Pennsylvania. After providing informed consent, research participants were screened for eligibility. The clinical trial was designed as a randomized crossover study in which participants underwent two frequently sampled intravenous glucose tolerance tests - one after receiving a subcutaneous injection of saline and one after receiving a subcutaneous injection of rapid-acting exenatide (BYETTA). The study sought to determine whether genetic variants are associated with the magnitude of the effect of exenatide. If an association were identified, this would help physicians to predict whether an individual patient is likely to have a large response to the class of diabetes drugs to which exenatide belongs (GLP1 receptor agonists).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland, Baltimore
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Member of the Old Order Amish community in Lancaster County, Pennsylvania

• BMI: 18-40 kg/sq.m.

Exclusion Criteria:

• Known allergy to exenatide

• History of diabetes, random glucose >200 mg/dL, or HbA1c > 6.5%

• Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or other diseases that the investigator judges will make interpretation of the results difficult or increase the risk of participation

• Seizure disorder

• Pregnant by self-report or known pregnancy within 3 months of the start of study

• Currently breast feeding or breast feeding within 3 months of the start of the study

• Estimated glomerular filtration rate <60 mL/min/1.73m2

• Hematocrit <35%

• Liver function tests greater than 2 times the upper limit of normal

• Abnormal TSH

• History of pancreatitis or pancreatic cancer. Personal or family history of medullary carcinoma of the thyroid.